Trial Outcomes & Findings for Diet and Hypertension Management in African Americans With Chronic Kidney Disease (NCT NCT04084574)

NCT ID: NCT04084574

Last Updated: 2025-01-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: Up to 12 weeks
• Results posted on: 2025-01-06

Participant Flow

Patients at a single academic medical center were recruited by invitation via their electronic patient portal or mailed letter.

Of 204 individuals who completed the pre-screening survey, 158 were eligible for further screening, 86 consented to the study, and 31 met final inclusion criteria and were randomized to the intervention or control group.

Participant milestones

Measure	Behavioral Diet Counseling Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition	Standard of Care Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
Overall Study STARTED	16	15
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	Behavioral Diet Counseling Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition	Standard of Care Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
Overall Study Lost to Follow-up	1	0
Overall Study Physician Decision	1	0
Overall Study Relocated out of state	1	0

Baseline Characteristics

Diet and Hypertension Management in African Americans With Chronic Kidney Disease

Baseline characteristics by cohort

Measure	Behavioral Diet Counseling n=16 Participants Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition	Standard of Care n=15 Participants Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition	Total n=31 Participants Total of all reporting groups
Age, Continuous	70.9 years STANDARD_DEVIATION 6.7 • n=5 Participants	72.7 years STANDARD_DEVIATION 6.2 • n=7 Participants	71.8 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks

Population: Only relevant to the Behavioral Diet Counseling arm.

Outcome measures

Measure	Behavioral Diet Counseling n=16 Participants Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition	Standard of Care Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
Number of Group Counseling Sessions Attended by Participants Randomized to the Treatment Arm	8.9 sessions per participant Standard Deviation 4.2	—

PRIMARY outcome

Timeframe: Baseline, 1 month, 3 months, 6 months

Number of randomized participants who provided blood and urine biospecimens, clinic and 24-hour ambulatory blood pressure measurements, and 24-hour dietary recall data during scheduled data collection visits at baseline, 1 month, 3 months, and 6 months.

Outcome measures

Measure	Behavioral Diet Counseling n=16 Participants Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition	Standard of Care n=15 Participants Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
Number of Participants Who Completed Data Collection Visits at Scheduled Study Timepoints Baseline	16 Participants	15 Participants
Number of Participants Who Completed Data Collection Visits at Scheduled Study Timepoints 1 month	14 Participants	15 Participants
Number of Participants Who Completed Data Collection Visits at Scheduled Study Timepoints 3 months	14 Participants	14 Participants
Number of Participants Who Completed Data Collection Visits at Scheduled Study Timepoints 6 months	13 Participants	15 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: Data not collected on 3 participants in the Behavioral Diet Counseling arm and 4 participants in the Standard of Care arm.

Change was measured by determining the difference in 24-hr mean systolic blood pressure (mmHg) obtained at 12 weeks (end of treatment) from baseline value.

Outcome measures

Measure	Behavioral Diet Counseling n=13 Participants Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition	Standard of Care n=10 Participants Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
Change in 24-hour Mean Systolic Blood Pressure	-0.9 mmHg Standard Deviation 16.1	4.0 mmHg Standard Deviation 9.1

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: Participants with data collected at both timepoints.

Change was measured by determining the difference in serum potassium at 12 weeks (end of treatment) from baseline value.

Outcome measures

Measure	Behavioral Diet Counseling n=14 Participants Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition	Standard of Care n=14 Participants Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
Change in Serum Potassium Concentration	0.06 mmol/L Standard Deviation 0.46	0.01 mmol/L Standard Deviation 0.53

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: Participants with data collected at both timepoints.

Change was measured by determining the difference in 24 hour urine sodium concentration at 12 weeks (end of treatment) from baseline value.

Outcome measures

Measure	Behavioral Diet Counseling n=14 Participants Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition	Standard of Care n=14 Participants Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
Change in 24 Hour Urine Sodium Concentration	-8.2 mmol/L/day Standard Deviation 37.1	-19.9 mmol/L/day Standard Deviation 75.3

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: Participants with data collected at both timepoints.

Change was measured by determining the difference in 24 hour urine sodium concentration at 12 weeks (end of treatment) from baseline value.

Outcome measures

Measure	Behavioral Diet Counseling n=14 Participants Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition	Standard of Care n=14 Participants Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
Change in 24 Hour Urine Sodium Concentration	-8.2 mmol/L/day Standard Deviation 37.1	-19.9 mmol/L/day Standard Deviation 75.25

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: Participants with data collected at both timepoints.

Change was measured by determining the difference in 24 hour urine phosphorus concentration at 12 weeks (end of treatment) from baseline value.

Outcome measures

Measure	Behavioral Diet Counseling n=14 Participants Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition	Standard of Care n=14 Participants Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
Change in 24 Hour Urine Phosphorus Concentration	-73.0 mg/dL/day Standard Deviation 180.9	-62.3 mg/dL/day Standard Deviation 197.3

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: Participants with data collected at both timepoints.

Change was measured by determining the difference in 24 hour urine urea nitrogen concentration at 12 weeks (end of treatment) from baseline value.

Outcome measures

Measure	Behavioral Diet Counseling n=14 Participants Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition	Standard of Care n=14 Participants Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
Change in 24 Hour Urine Urea Nitrogen Concentration	-0.5 mcg/mL Standard Deviation 2.5	-1.07 mcg/mL Standard Deviation 3.9

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Participants with data collected at both timepoints.

Change was measured by determining the difference in clinic mean systolic blood pressure (mmHg) obtained at 12 weeks (end of treatment) from baseline value.

Outcome measures

Measure	Behavioral Diet Counseling n=14 Participants Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition	Standard of Care n=14 Participants Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
Change in Clinic Mean Systolic Blood Pressure	4.6 mmHg Standard Deviation 21.5	-2.4 mmHg Standard Deviation 22.2

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Participants with data collected at both timepoints.

Change was measured by determining the difference in body weight obtained at 12 weeks (end of treatment) from baseline value.

Outcome measures

Measure	Behavioral Diet Counseling n=14 Participants Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition	Standard of Care n=14 Participants Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
Change in Body Weight	0.16 kg Standard Deviation 1.65	-1.18 kg Standard Deviation 3.76

SECONDARY outcome

Timeframe: 12 weeks to 24 weeks

Population: Participants with data collected at both timepoints.

Change was measured by determining the difference in mean clinic systolic blood pressure (mmHg) obtained at 24 weeks from 12 weeks.

Outcome measures

Measure	Behavioral Diet Counseling n=13 Participants Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition	Standard of Care n=13 Participants Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
Change in Mean Clinic Systolic Blood Pressure From 12 Weeks (End of Treatment) to 24 Week Observation	-7.9 mmHg Standard Deviation 13.9	-5.2 mmHg Standard Deviation 13.3

SECONDARY outcome

Timeframe: 12 weeks to 24 weeks

Population: Participants with data collected at both timepoints.

Change was measured by determining the difference in body weight obtained at 24 weeks from 12 weeks.

Outcome measures

Measure	Behavioral Diet Counseling n=13 Participants Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition	Standard of Care n=13 Participants Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
Change in Body Weight From 12 Weeks (End of Treatment) to 24 Week Observation	-0.77 kg Standard Deviation 1.97	0.62 kg Standard Deviation 1.62

SECONDARY outcome

Timeframe: 12 weeks to 24 weeks

Population: Participants with data collected at both timepoints.

Change was measured by determining the difference in DASH diet score obtained at 24 weeks from 12 weeks. The DASH score, ranging from 8 to 40 points with eight components, focuses on food and nutrients for managing hypertension. The eight components are "fruits", "vegetables", "nuts and legumes", "whole grains", "low-fat dairy", "sodium", "red and processed meats", and "sweetened beverages". A higher score indicates better diet quality.

Outcome measures

Measure	Behavioral Diet Counseling n=12 Participants Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition	Standard of Care n=12 Participants Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
Change in DASH Diet Score From 12 Weeks (End of Treatment) to 24 Week Observation	0.25 score on a scale Standard Deviation 1.41	0.25 score on a scale Standard Deviation 1.00

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Participants with data collected at both timepoints.

Change was measured by determining the difference in DASH diet score obtained at 24 weeks from 12 weeks. The DASH score, ranging from 8 to 40 points with eight components, focuses on food and nutrients for managing hypertension. The eight components are "fruits", "vegetables", "nuts and legumes", "whole grains", "low-fat dairy", "sodium", "red and processed meats", and "sweetened beverages". A higher score indicates better diet quality.

Outcome measures

Measure	Behavioral Diet Counseling n=13 Participants Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition	Standard of Care n=13 Participants Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
Change in DASH Diet Score From Baseline to 12 Weeks (End of Treatment)	0.15 score on a scale Standard Deviation 1.26	-0.14 score on a scale Standard Deviation 1.69

Adverse Events

Behavioral Diet Counseling

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Behavioral Diet Counseling n=16 participants at risk Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition	Standard of Care n=15 participants at risk Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
Renal and urinary disorders Acute kidney injury	0.00% 0/16 • Up to 6 months	6.7% 1/15 • Up to 6 months
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/16 • Up to 6 months	6.7% 1/15 • Up to 6 months
Metabolism and nutrition disorders Hyperkalemia	6.2% 1/16 • Up to 6 months	0.00% 0/15 • Up to 6 months

Additional Information

Crystal Tyson, MD, MHS

Duke University

Phone: 919-660-6671

Email: crystal.simpson@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place